The Cesarean Study: Optimizing Cesarean Sections and Improving Patient-Healthcare Provider Trust Using Evidence Informed Recommendations

Rising CS rates globally and across Europe pose a growing challenge to maternal-newborn health (1). In some European countries, CS rates have soared to 55%, and in Sweden, almost 20,000 procedures are performed annually, with numbers continuing to rise (2, 3). Strikingly, nearly 40% of these are planned cesareans, highlighting a critical need to change on-going clinical practices, especially for low-risk pregnancies, which are well-known drivers of CS rates (5, 6). These rates also contradict the World Health Organization's (WHOs) recommendations that CS rates above 10-15% are not associated with improved maternal-newborn outcomes (5). The WHO has provided clear guidance for reducing non-essential CS (5, 6), emphasizing evidence-based strategies such as requiring a second clinician's sign-off and fostering multidisciplinary reflection, both of which are key parts of the Cesarean study's intervention.

Qualitative evidence from Kingdon et al. (7,8) has shown that women want their birth preferences acknowledged, value individualized information, and are influenced by how health professionals communicate, making shared decision-making essential. However, studies from Quebec (9) and Spain (10) revealed that there are some persistent barriers to implementing guidelines, such as fragmented care and inconsistent messaging, which reinforce the well-known "know-do gap" where best practices fail to reach routine care. The Cesarean Study responds directly to this need, testing a three-part therapy bundle aligned with WHOs recommendations for maximal impact.

Population Pregnant women remitted to clinicians for planned CS discussion.

Intervention

The "Cesarean Bundle", a three-part, decision-support model, comprising of:

I. The Cesarean Discussion Guide, which is a structured clinical tool designed to facilitate personalized, evidence-based conversations between clinicians and patients considering planned cesarean birth. It captures key clinical data, patient values, and birth preferences, integrates risk stratification using the Robson Classification (11-13), and presents short- and long-term outcomes of cesarean versus vaginal birth in a clear, visual format. By standardizing counseling and embedding shared decision-making into routine care, the guide supports more equitable, informed, and patient-centered birth planning. The principal investigator (MZ) has developed the guide with support from Ariadne Labs, Boston USA.

II. Mandatory second opinion/team decision from another clinician for all planned cesarean requests; and, III. Regular team audits reviewing decision-making patterns.

Standard care, consisting of usual clinical consultations for discussing and approving planned CS, without structured guidance or required secondary clinician or team review.

Outcomes Primary outcome Patient-reported trust in the care team, measured by the Health Care Relationship Trust Scale-Revised (HCRTS-R) (14)

Secondary outcomes i) Change in planned CS rate before and after intervention, including subdivisions by Robson Groups for risk stratification ii) Composite of severe neonatal outcomes, including perinatal mortality, 5-min Apgar score <6, hypoxic ischemic encephalopathy grade II-III, intracranial hemorrhage, neonatal seizures, neonatal infection, hypoglycemia, respiratory distress, umbilical arterial pH< 7.05 iii) Composite of severe maternal outcomes, including postpartum hemorrhage (>1000ml), ICU admission, postpartum infection iv) Twelve question survey for clinicians and patients reporting experience of usability, acceptability, feasibility of intervention vs standard care v) Qualitative interviews using the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) (15) to evaluate the impact and real-world applicability of the Cesarean Bundle across patient, partner, clinician, and system levels vi) Cost-analysis of intervention vs standard care.

Inclusion criteria

• Pregnant women aged ≥18 years
• Referred for consultation regarding planned cesarean section
• Able to provide informed consent (with interpreter support if needed)

Exclusion criteria

• Women with an absolute medical indication for cesarean section (e.g., placenta previa), where shared decision-making is not applicable
• Women who decline participation in the study components (e.g., surveys/interviews)